Department of Ophthalmology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.
Department of Ophthalmology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.
Ophthalmology. 2014 Jan;121(1):150-161. doi: 10.1016/j.ophtha.2013.08.015. Epub 2013 Sep 29.
To describe risk factors for geographic atrophy (GA) in the Comparison of Age-related Macular Degeneration Treatments Trials (CATT).
Cohort within a randomized clinical trial.
We analyzed 1024 CATT patients with no GA visible on color fundus photographs (CFPs) and/or fluorescein angiograms (FAs) at enrollment.
Eyes were assigned to ranibizumab (0.5 mg) or bevacizumab (1.25 mg) treatment and to a 2-year monthly or pro re nata (PRN) injection regimen, or monthly injections for 1 year and PRN for 1 year. Demographic, genetic, and baseline ocular characteristics and lesion features of CFP/FA and optical coherence tomography (OCT) were evaluated as risk factors for GA through 2 years of follow-up. Time-dependent Cox proportional hazard models were used to estimate adjusted hazard ratios (aHRs).
Development of GA.
By 2 years, GA developed in 187 of 1024 patients (18.3%). Baseline risk factors for GA development included baseline visual acuity (VA) ≤20/200 (aHR, 2.65; 95% confidence interval [CI], 1.43-4.93), retinal angiomatous proliferation (RAP; aHR, 1.69; 95% CI, 1.16-2.47), GA in the fellow eye (aHR, 2.07; 95% CI, 1.40-3.08), and intraretinal fluid at the foveal center (aHR, 2.10; 95% CI, 1.34-3.31). Baseline factors associated with lower risk for GA development included blocked fluorescence (aHR, 0.49; 95% CI, 0.29-0.82), OCT measurements of subretinal fluid thickness of >25 μ (aHR, 0.52; 95% CI, 0.35-0.78), subretinal tissue complex thickness of >275 compared with ≤75 μ (aHR, 0.31; 95% CI, 0.19-0.50), and vitreomacular attachment (aHR, 0.55; 95% CI, 0.31-0.97). Ranibizumab compared with bevacizumab had a higher risk (aHR, 1.43; 95% CI, 1.06-1.93), and monthly dosing had a higher risk (aHR, 1.59; 95% CI, 1.17-2.16) than PRN dosing. There were no strong associations between development of GA and the presence of risk alleles for CFH, ARMS 2, HTRA1, C3, or TLR3.
Approximately one fifth of CATT patients developed GA within 2 years of treatment. Independent baseline risk factors included poor VA, RAP, foveal intraretinal fluid, monthly dosing, and treatment with ranibizumab. Anti-vascular endothelial growth factor therapy may have a role in the development of GA.
描述年龄相关性黄斑变性治疗试验比较（CATT）中地图状萎缩（GA）的风险因素。
随机临床试验中的队列。
我们分析了 1024 名 CATT 患者，他们在入组时的眼底彩色照片（CFP）和/或荧光素血管造影（FA）上看不到 GA。
将眼睛分配给雷珠单抗（0.5mg）或贝伐单抗（1.25mg）治疗，并进行为期 2 年的每月或按需（PRN）注射方案，或进行 1 年的每月注射和 1 年的 PRN 注射。通过 2 年的随访，评估人口统计学、遗传和基线眼部特征以及 CFP/FA 和光相干断层扫描（OCT）的病变特征，作为 GA 发展的风险因素。使用时间依赖性 Cox 比例风险模型来估计调整后的风险比（aHR）。
GA 的发展。
在 1024 名患者中，183 名（18.3%）在 2 年内发展为 GA。GA 发展的基线风险因素包括基线视力（VA）≤20/200（aHR，2.65；95%置信区间[CI]，1.43-4.93）、视网膜血管性增殖（RAP；aHR，1.69；95%CI，1.16-2.47）、对侧眼 GA（aHR，2.07；95%CI，1.40-3.08）和中心凹视网膜内液（aHR，2.10；95%CI，1.34-3.31）。与 GA 发展风险较低相关的基线因素包括荧光封闭（aHR，0.49；95%CI，0.29-0.82）、OCT 测量的视网膜下液厚度>25μ（aHR，0.52；95%CI，0.35-0.78）、视网膜下组织复合体厚度>275μ与≤75μ（aHR，0.31；95%CI，0.19-0.50）和玻璃体黄斑附着（aHR，0.55；95%CI，0.31-0.97）。与贝伐单抗相比，雷珠单抗的风险更高（aHR，1.43；95%CI，1.06-1.93），每月给药的风险更高（aHR，1.59；95%CI，1.17-2.16），而不是按需给药。GA 的发展与 CFH、ARMS2、HTRA1、C3 或 TLR3 风险等位基因之间没有强烈的关联。
大约五分之一的 CATT 患者在治疗后 2 年内发生了 GA。独立的基线风险因素包括视力差、RAP、中心凹内视网膜内液、每月给药和雷珠单抗治疗。抗血管内皮生长因子治疗可能在 GA 的发展中起作用。
